FDA Issues New Guidance Detailing ASCA Pilot Program for Devices

A trio of guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices.

Under the new program, the agency plans to accredit testing laboratories, including some in-house testing laboratories, to assess the conformance of a device with certain FDA-recognized standards.

A device manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity from the accredited lab as part of a premarket submission to the FDA.